Talimogene laherparepvec is under clinical development by Amgen and currently in Phase II for Metastatic Renal Cell Carcinoma. According to GlobalData, Phase II drugs for Metastatic Renal Cell Carcinoma have a 40% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Talimogene laherparepvec’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Talimogene laherparepvec overview
Talimogene laherparepvec (Imlygic) is a recombinant herpes simplex type-1 virus (HSV), acts as immunostimulating and antineoplastic agent. It is formulated as injectable suspension and solution for intralesional route of administration. Imlygic is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Imlygic has not been shown to improve overall survival or have an effect on visceral metastases.
It is under development for the treatment of Kaposi sarcoma, cutaneous angiosarcoma, pleomorphic liposarcoma, locally advanced basal cell carcinoma,HER2 negative breast cancer, triple negative breast cancer, hepatocellular carcinoma, pancreatic cancer including metastatic pancreatic adenocarcinoma, non-small cell lung cancer, renal cell carcinoma, gastroesophageal cancer, pancreatic ductal adenocarcinoma, Merkel cell carcinoma, malignant pleural effusion, metastatic recurrent squamous cell carcinoma of head and neck of the oral cavity, cutaneous squamous cell carcinoma, metastatic colorectal cancer with liver metastasis, metastatic breast cancer and other rare skin tumors, oropharynx, hypopharynx, or larynx, soft tissue sarcoma as second and third line therapy, and other solid tumors including inflammatory breast cancer. It is administered through intravesical, intratumor, intrapleural and intralesional route. It was also under development for non-muscle invasive transitional cell carcinoma (second line therapy), refractory T cell and NK cell lymphomas (cutaneous T-cell lymphomas (CTCL), mycosis fungoides (MF), Sezary syndrome (SS), peripheral T-cell lymphoma (PTCL), ALK-positive and ALK-negative anaplastic large cell lymphoma (ALCL)), extramammary Paget Disease, cutaneous squamous cell carcinoma, non-melanomatous skin cancer.
Amgen is a biotechnology company, which discovers, develops, manufactures, and markets innovative human medicines to treat patients suffering from serious diseases. It develops novel medicines in therapeutic areas of cardiovascular, oncology/hematology, inflammation, bone health, neurological disorders and nephrology. The company develops products using advanced human genetics to analyze the difficulties of disease and understand the fundamentals of human biology. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels and through partnerships with other companies. The company has presence in Asia Pacific, Europe, Middle East, North America and Australia. Amgen is headquartered in Thousand Oaks, California, the US.
For a complete picture of Talimogene laherparepvec’s drug-specific PTSR and LoA scores, buy the report here.